FDA Recall
Terminated
Historical recordClass II
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transdermal cream, dispensed in a) 3 mL and b) 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes,Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 8 MG/ML transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML transdermal cream, dispensed in 10 mL prefilled syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
by the Compounder
- Reason
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
by Breckenridge Pharmaceutical, Inc
- Reason
- Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel)
by C. O. Truxton
- Reason
- Labeling: Wrong Bar Code
- Published
- November 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
by Valeant Pharmaceuticals North America LLC
- Reason
- Failed Dissolution Specifications: Failed 24 month dissolution testing.
- Published
- November 11, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Reason
- Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
- Published
- November 11, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01
by Pfizer Inc.
- Reason
- Subpotent Drug
- Published
- November 4, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VITAMIN D3 OIL, Injectable Solution, 50,000 UNITS/ML, syringe sizes: 10 mL and 30 mL, Rx only,JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
by JD & SN Inc., dba Moses Lake Professional Pharmacy
- Reason
- Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
- Published
- November 4, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VITAMIN D3 OIL, Injectable Solution, 400,000 UNITS/ML, syringe size: 20 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
by JD & SN Inc., dba Moses Lake Professional Pharmacy
- Reason
- Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
- Published
- November 4, 2015
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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